Date Initiated by Firm | March 05, 2015 |
Date Posted | April 21, 2015 |
Recall Status1 |
Terminated 3 on June 15, 2015 |
Recall Number | Z-1479-2015 |
Recall Event ID |
70488 |
510(K)Number | K123164 |
Product Classification |
Tape, measuring, rulers and calipers - Product Code FTY
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Product | SpineFrontier MISquito Percutaneous Pedicle Screw System Surgical Technique; Part Number: DOC80023. The Rod Caliper is a manual surgical instrument that may be used as part of the PedFuse Pedicle Screw System and its MISquito components during percutaneous, minimally invasive surgical (MIS) technique of posterior pedicle screw fixation. |
Code Information |
Revision E |
Recalling Firm/ Manufacturer |
SpineFrontier, Inc. 500 Cummings Ctr Ste 3500 Beverly MA 01915-6516
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For Additional Information Contact | 978-232-3990 |
Manufacturer Reason for Recall | The PedFuse Pedicle Screw Rod Caliper included with the MISquito Pedicle Screw System may be used incorrectly as the Surgical Technique does not adequately convey the intended use of the design. |
FDA Determined Cause 2 | Labeling design |
Action | SpineFrontier sent an Urgent Advisory Notice letter to customers via email. The letter identified the affected product, problem and actions to be taken. Customers were asked complete and return the Acknowledgement Form to confirm receipt of the recall notification. For questions call 978-232-3990. |
Quantity in Commerce | 5 devices |
Distribution | US Nationwide Distribution in the states of TX, KS, CO, and MA |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database | 510(K)s with Product Code = FTY
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